Glabellar Frown Lines Clinical Trial
Official title:
A Phase 3b, Randomized, Double-Blind, Placebo-Controlled Study to Assess Aesthetic Improvement and Onset of QM1114-DP Treatment Effect in Subjects With Moderate to Severe Glabellar Lines
Verified date | February 2023 |
Source | Galderma R&D |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to evaluate the aesthetic improvement and onset of QM1114-DP treatment for subjects with moderate to severe glabellar lines
Status | Completed |
Enrollment | 132 |
Est. completion date | September 1, 2023 |
Est. primary completion date | October 28, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Male or Female 18 years or older - Moderate to severe GL at maximum frown as assessed by the Investigator - Moderate to severe GL at maximum frown as assessed by the subject Exclusion Criteria: - Previous use of any botulinum toxin in facial areas within 9 months prior to study treatment - Female who is pregnant, breast feeding or intends to conceive a child during the study. |
Country | Name | City | State |
---|---|---|---|
United States | Galderma Research Site | Chapel Hill | North Carolina |
United States | Galderma Research Site | Coral Gables | Florida |
United States | Galderma Research Site | Homewood | Alabama |
United States | Galderma Research Site | Hunt Valley | Maryland |
United States | Galderma Research Site | Manhattan Beach | California |
United States | Galderma Research Site | Omaha | Nebraska |
United States | Galderma Research Site | Pflugerville | Texas |
United States | Galderma Research Site | Spring | Texas |
United States | Galderma Research Site | Vista | California |
Lead Sponsor | Collaborator |
---|---|
Galderma R&D |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Responders in QM1114-DP versus Placebo using the Global Aesthetic Improvement Scale (GAIS) at maximum frown at Month 1 | Responder Rate is defined as a subject who responds at least Improved on the GAIS at maximum frown | 1 month |
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